Passiflora edulis como terapia adjuvante à insulina na diabetes tipo 1: caracterização de pacientes de um ensaio clínico randomizado

Abstract

Type 1 diabetes, characterized by insulin deficiency, affects around 600,000 Brazilians. In some cases, insulin therapy is insufficient and alternatives such as Passiflora edulis (P. edulis) are explored as adjuvant therapies. This study aims to characterize the clinical and laboratory characteristics of type 1 diabetic patients included in a randomized clinical trial that used the hydroethanolic extract of P. edulis as an adjuvant therapy to insulin. This is a phase 2, randomized, double-blind, placebo-controlled clinical trial carried out at the teaching hospital's endocrinology outpatient clinic over 90 days. Thirteen patients were included out of an expected 56 patients with DM1, and received treatment with P. edulis extract (1600mg/day) adjuvant to insulin (n=28) or placebo (n=28). After signing the Informed Consent Form (ICF), blood and urine were collected from all the patients, the Hypoglycemia Fear Survey (HFS-II) was applied and their blood glucose was continuously monitored using the Freestyle libre. Biochemical parameters and urinary nephrin expression were assessed. The study remained blinded. Significantly higher initial HFS-II scores were observed in participants aged over 40 (p=0.008). After 90 days of treatment with P. edulis, the HFS-II revealed a significant decrease in the fear of hypoglycemia (p=0.020). Nephrin was detected in the patients' urine at the beginning and end of treatment. The results suggest the need for strict glycemic control to prevent diabetes complications and the relevance of nephrin as an early biomarker.